检验项目(Items) 标准规定(Specifications) 检验结果(Results)
性状(Characters) 黄色粉末(Yellow powder) 黄色粉末(Yellow powder)
鉴别(Identification) 应符合规定 (Complies) 符合规定(Complies)
pH 2.0-3.0 2.7
比旋度(Specific optical rotation)-248°-- -263° -254°
吸收系数(385nm) 340-370 356
Specific absorbance (385nm )
有关物质(Related substances)
任一杂质 不得超过5.0%,仅允许一杂质过4.0% 符合规定
Any impurity Not more than 5.0%,only one more than4.0% Complies
总杂质(Total) 不得超过10.0% (Not more than 10.0%) 符合规定(Complies)
重金属(Heavy metals) 不得过50ppm (maximum 50 ppm) ＜50ppm
水分(Water) 不得过3.0% (maximum3.0) 0.3%
硫酸灰分(Sulphated ash) 不得过0.5% (maximum0.5%) 0.1%
含量(无水物) 89.5%-102.0% 93.6%
Assay(Anhydrous substance)
结论:符合欧洲药典5.0版规定
Conclusion:complies with EP5.0
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